Ibrutinib-rituximab therapy is superior to gold standard therapy for CLL

According to a latest report, ibrutinib-rituximab (IR) therapy offers superior progression free survival (PFS) than fludarabine, cyclophosphamide, and rituximab (FCR) in patients with immunoglobulin heavy chain variable region (IGHV) gene mutated or unmutated chronic lymphocytic leukemia (CLL). This was an updated report from the E1912 trial published in the journal, Blood (American Society of Hematology).

The initial E1912 report suggested that IR therapy provides superior PFS and overall survival (OS), when compared to FCR. However, the OS advantage was small, and it could be attributed to the early deaths in the FCR arm. Moreover, no statistically significant difference was reported in PFS between the groups in patients with IGHV. The current report provides an update on the adverse events (AEs), PFS, OS, and long-term tolerability of single-agent ibrutinib, after 3 years of follow-up.

529 treatment-naïve patients, enrolled in the study were randomized (2:1 ratio) to receive IR or 6 cycles of FCR.

After a median follow-up of 5.8 years, median PFS was found to be superior for IR in relative to FCR in patients with both IGHV gene mutated and IGHV unmutated CLL. Of the 354 patients randomized to IR, 214 (60.5%) currently remain on ibrutinib. Sustained improvement in overall survival (OS) was observed for patients in the IR arm.

Thus, this report of the ongoing E1912 trial suggests that IR therapy offers superior PFS and OS relative to FCR in patients with IGHV mutated or unmutated CLL. Continuous ibrutinib therapy is tolerated beyond 5 years in the majority of CLL patients.